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Latex Urethral Catheter
EUDAMEDClass IIa (EU MDR)
Ref EC010216RModel 2way Standard ，5.3mm(16Fr），5ml/10ml/15ml/30ml
Identity
- Trade Name
- Latex Urethral Catheter EUDAMED
- Device Name
- Latex Urethral Catheter EUDAMED
- Model / Reference
- 2way Standard ，5.3mm(16Fr），5ml/10ml/15ml/30ml EUDAMEDEC010216R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973362560113 EUDAMED
- Basic UDI-DI
- B-06973362560113 EUDAMED
- EMDN Code
- U010201 URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Latex Urethral Catheter by Guangdong Ecan Medical Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06973362560113 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guangdong Ecan Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000020906
- Authorised Representative
- phoenix Medtech GmbH DE-AR-000007996
Sources (1)
- EUDAMED 32510781-90a5-4d8c-9a1c-258b13a6061c 61 fields · synced Jun 18, 2026